Active substanceSparfloxacinSparfloxacin
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  • Sparflo®
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  • Sparfloxacin
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    AVVA RUS, OJSC     Russia
  • Dosage form: & nbspfilm coated tablets
    Composition:

    One tablet contains:

    Active substance: sparfloxacin (in terms of 100 % substance) - 200.0 mg.

    Excipients: giprolase - 12.0 mg, corn starch - 10.0 mg, silicon dioxide colloid - 3.0 mg, crospovidone - 3.0 mg, magnesium stearate - 3.0 mg, microcrystalline cellulose - to obtain a tablet without a coat of 300, 0 mg.

    Shell accessories: a mixture for the preparation of film coating "Instakoat Aqua II" [polyvinyl alcohol - 45.0%, titanium dioxide - 13.0%, talc - 4.0%, macrogol - 14.0%, triacetin - 4.0%, calcium phosphate - 20.0%] - to obtain a tablet with a coating weight of 310.0 mg.

    Description:

    Round biconvex tablets, covered with a film coat from white to light yellow color. On the cross-section the nucleus is from light yellow to yellow.

    Pharmacotherapeutic group:Antimicrobial agent, fluoroquinolone
    ATX: & nbsp

    J.01.M.A   Fluoroquinolones

    J.01.M.A.09   Sparfloxacin

    Pharmacodynamics:

    The antimicrobial agent, a derivative of fluoroquinolone, inhibits bacterial DNA gyrase, despiralizing regions of chromosomal DNA. Low toxicity for human body cells is due to the lack of DNA-gyrase in them.

    Sparfloxacin has bactericidal activity and a broad spectrum of antimicrobial activity both in gram-positive and gram-negative flora. The advantage of the drug is a high activity against Gram-positive cocci and anaerobes in comparison with the fluoroquinolones of previous generations. Gram-positive bacteria have a bactericidal effect only in the period of division, on gram-negative - and during rest, because it affects not only DNA-gyrase, but also causes lysis of the cell wall.

    Prevents the transcription of the genetic material of bacteria necessary for their normal metabolism, which leads to a rapid decrease in the ability of bacteria to divide. As a result of the drug, there is no parallel development of resistance to other antibiotics that are not gyrase inhibitors, which makes Sparfloxacin highly effective against bacteria, resistant, for example, to aminoglycosides, penicillins, cephalosporins, tetracyclines and other antibiotics.

    The following pathogenic microorganisms are highly sensitive to sparfloxacin: Esche­richia coli, Shigella spp., Salmonella spp, Citrohacter spp., Klebsiella spp., Enterobacter spp., Serratia spp., Hafnia spp., Edwardsiella spp., Proteus spp. (indole-positive and indolotric), Providencia spp., Morganella spp., Yersinia spp., Vibrio spp., Aeromonas spp., Plesiomonas spp., Pasteurella spp., Haemophilus spp., Campylobacter spp., Pseudomonas cepatia, Pseudomonas aerugenosa, Legionella spp., Neisseria spp., Moraxella spp., Acinetobacter spp., Brucella spp., Staphylococcus spp., Streptococcus pneumoniae, Mycoplasma pneumoniae, Listeria spp., Corynebacterium spp., Chlamydia spp., Xanthomonas maltophilia. Sparfloxacin is characterized by high activity in Mycobacterium tuber­culosis, including multidrug-resistant strains.

    Enterococcus faecium, Ureaplasma urealyticum, Nocardia asteroides, as a rule, sensitive to sparfloxacin.

    The following microorganisms have a moderate sensitivity: Gardnerella spp., Flavobacterium spp., Alcaligenes spp., Streptococcus agalactiae, Enterococcus faecalis, Strep­tococcus pyogenes, Streptococcus viridians, Mycoplasma hominis, Mycobacterium fortuitum.

    With some exceptions, anaerobic microorganisms are moderately sensitive (Peptococcus spp., Pepptostreptococcus spp.) or sustainable (Bacteroides spp.). Sparfloxacin is not effective against Treponema pallidum.

    With respect to gram-negative flora, it exhibits activity close to aminoglycosides.

    Resistance to sparfloxacin develops extremely slowly, because, on the one hand, after its action, there are practically no persistent microorganisms, and on the other hand - bacterial cells do not have enzymes that can inactivate it.

    No cross-resistance to other antimicrobials has been observed.

    In a relationship Pseudomonas aeruginosa and other gram-negative bacilli by activity is inferior to ciprofloxacin.

    Has a postantibiotic effect: microorganisms do not multiply within 0.5-4 h after the drug disappears from the plasma.

    Pharmacokinetics:

    Absorption after oral administration - about 90%. The degree of absorption does not change when taking the drug with food or milk. The food slows the rate of absorption, but does not change the degree of absorption, so that the maximum concentration of sparfloxacin is observed about 30 minutes later than when taken on an empty stomach.

    It is well distributed in the tissues of the body (with the exception of tissue rich in fats, including nervous tissue), the concentration in the tissues and fluids of the lower respiratory tract exceeds the concentration in the plasma. It is found in high concentrations in alveolar macrophages. Therapeutic concentrations are achieved in saliva, bile, intestines, abdominal and pelvic organs, kidneys and urinary organs, pulmonary tissue, bronchial secretion, bone tissue, muscles, synovial fluid and articular cartilage, peritoneal fluid, skin. In spinal and ocular fluids, only 10% of the concentration of the drug in the plasma.

    The preparation has a large volume of distribution - 3.9 ± 0.8 l / kg, exceeding this figure for other fluoroquinolones. The connection with plasma proteins (mainly albumins) is about 45%.

    Time to reach the maximum concentration after ingestion 400 mg - 3-6 h, the concentration in the tissues is 2-12 times higher than in the plasma. The concentration of the drug in the blood serum has a linear dependence on the value of the dose taken.

    The activity decreases slightly at acidic pH values.

    Metabolized in the liver, excreted with a fecal mass (30-50%) and urine (tubular filtration and tubular secretion) - of them, unchanged, about 10% of the orally taken dose. The half-life is 16-30 hours, in patients with renal insufficiency the half-life is prolonged.

    In chronic renal failure, the percentage of the drug excreted through the kidneys decreases, but with creatinine clearance above 20 ml / min, no cumulation takes place in the body, because in parallel, there is an increase in metabolism and excretion with calves.

    Indications:

    Infectious-inflammatory diseases caused by sensitive microflora:

    - Respiratory tract infections: pneumonia, chronic obstructive pulmonary disease in the acute stage, caused by Streptococcus pneumoniae, Staphylococcus spp., Haemophylus influenzae, Haemophylus parainfluenzae, Moraxella catarrhalis, Klebsiella pneumoniae, Enterobacter cloacae, Mycoplasma pneumonia, Chlamidia pneumoniae;

    - Infections of the middle ear, paranasal sinuses, especially if they are caused by gram-negative pathogens, including Pseudomonas spp. or Staphylococcus spp.;

    - Eye infections;

    - Infections of the kidneys and urinary tract (cystitis, non-gonococcal urethritis, pyelitis);

    - Infections of sexual organs (including adnexitis, prostatitis);

    - Infections of the abdominal cavity (bacterial infections of the gastrointestinal tract, including those caused by shigella and salmonella, bile ducts);

    - Infections of the skin and soft tissues (abscess, pyoderma, furunculosis, infectious dermatitis);

    - Infections of bones and joints (including osteomyelitis);

    - Infections against the background of immunodeficiency, including on the background of treatment with immunosuppressive drugs or in patients with neutropenia;

    - Diseases transmitted sexually (gonorrhea, chlamydia);

    - Tuberculosis of the lungs (for treatment of drug-resistant tuberculosis or intolerance of first-line therapy);

    - Leprosy.

    When using the drug Sparfloxacin should take into account the official national recommendations for the proper use of antibacterial drugs, as well as the sensitivity of pathogenic microorganisms in a particular country.

    Contraindications:

    Hypersensitivity to sparfloxacin, other fluoroquinolones or drug components, epilepsy, age to 18 years (incomplete skeletal process), congenital or acquired lengthening syndrome QT, severe electrolyte disturbances, especially uncorrected hypokalemia; clinically significant bradycardia; clinically significant heart failure with a reduced fraction of the left ventricular ejection; presence in the anamnesis of rhythm disturbances, accompanied by clinical symptoms; simultaneous reception of drugs that extend the interval QT (see the section "Interaction with other drugs"), deficiency of glucose-6-phosphate dehydrogenase, severe renal failure, pregnancy, the period of breastfeeding, tendon damage with previous treatment with fluoroquinolones.

    Reactions of photosensitization in the anamnesis; conditions of life (professional activity), not allowing to limit insolation.

    Carefully:

    Patients predisposed to the development of seizures (in patients with previous lesions of the central nervous system (CNS), such as a pronounced cerebral atherosclerosis, cerebrovascular disease history, organic CNS, brain trauma history.

    In patients who simultaneously receive drugs that reduce the threshold of seizure activity in the brain, such as fenbufen or other non-steroidal anti-inflammatory drugs, theophylline).

    In patients with potentially proarrhythmic conditions (especially in women and elderly patients), such as acute myocardial ischemia and cardiac arrest. With myasthenia gravis gravis.

    With simultaneous reception with drugs that reduce the content of potassium.

    Chronic renal failure.

    In patients with severe adverse reactions to other fluoroquinolones, such as severe neurologic reactions (increased risk of similar undesirable reactions with sparfloxacin).

    In patients with hepatic insufficiency (control of liver function tests).

    In patients with diabetes mellitus, receiving oral hypoglycemic agents (for example, glibenclamide) or insulin (the risk of developing hypoglycemia increases)

    In patients with psychoses and other psychiatric disorders in the anamnesis.

    Pregnancy and lactation:

    Sparfloxacin is contraindicated in pregnancy and during breast feeding.

    There are no direct indications of embryotoxic and tocolytic effects of sparfloxacin.

    Dosing and Administration:

    Adults, inside, regardless of food intake (without chewing, drinking with a sufficient amount of liquid). The length of the course of treatment depends on the nature and severity of the disease and the type of pathogen.

    Pneumonia, exacerbation of chronic bronchitis - on the first day 400 mg once, then 200 mg / day for 10 days; patients with creatinine clearance less than 50 ml / min - on the first day 400 mg once, then 200 mg every 48 hours.

    Infections of the ENT organs, sinusitis - on the first day 400 mg once, then 200 mg per day for 10 days.

    When pulmonary tuberculosis is used as part of complex therapy with anti-TB drugs - on the first day 400 mg once, then 200 mg per day for 3 months.

    Urinary tract infections: on the first day, 200 mg once, then 100 mg once a day for 10-14 days.

    Acute gonorrheal urethritis: on the first day 400 mg once, then strictly after 24 hours - 200 mg, course dose 600 mg.

    Non-gonococcal urethritis - on the first day 200 mg once, then 100 mg once a day for 6 days.

    Bacterial prostatitis - on the first day 400 mg once, then 200 mg per day for 10-14 days.

    Chlamydial infections - on the first day 400 mg, then 200 mg for 10-14 days. Infections of the skin and soft tissues - on the first day 400 mg once, then 200 mg once a day for 3-9 days.

    Leprosy: 200 mg once a day for 12 weeks.

    Side effects:

    From the cardiovascular system: interval lengthening Q-T, tachycardia, cerebral artery thrombosis, acute myocardial ischemia and cardiac arrest, arrhythmia, ventricular tachycardia (torsade de pointes), vasodilation.

    From the digestive system: loss of appetite, nausea, vomiting, dyspepsia, abdominal pain, flatulence, diarrhea, cholestatic jaundice (especially in patients with liver disease), hepatitis, hepatonecrosis, impaired liver function, pseudomembranous colitis.

    From the respiratory system: dyspnea.

    From the nervous system: dizziness, headache, fatigue, drowsiness, anxiety, tremor, peripheral paralysis (anomaly of perception of pain), increased sweating, increased intracranial pressure, nightmares, confusion, depression, hallucinations, psychotic reactions, fainting, convulsions , severe neurological reactions, peripheral neuropathy, drowsiness.

    From the sense organs: violation of taste and smell, visual impairment (eg diplopia, change in color perception), tinnitus, hearing loss.

    From the urinary system: hematuria, crystalluria (especially with alkaline urine and low diuresis).

    From the musculoskeletal system: arthralgia, asthenia, myalgia, tendovaginitis, myasthenia gravis gravis, rupture of tendons.

    Allergic reactions: itching, drug fever, pinpoint hemorrhages (petechiae), nodal erythema, edema of the face, vessels or larynx, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylactic and anaphylactoid reactions.

    From the laboratory indicators: eosinophilia, leukopenia, granulocytopenia. anemia, thrombocytopenia; leukocytosis, thrombocytosis, hemolytic anemia, increased activity of "liver" transaminases and alkaline phosphatase, hyperprothrombinemia, hypercreatininaemia, hyperbilirubinemia, hypokalemia, hyperglycemia, hypoglycemia.

    Other: photosensitization, "tides" of blood to the face, exacerbation of porphyria in patients with porphyria.

    Overdose:

    Treatment: a specific antidote is unknown. Symptomatic therapy, if necessary - hemodialysis and peritoneal dialysis.

    Interaction:

    With drugs that can reduce the threshold of seizure activity of the brain, for example, theophylline, fenbufen (and other similar nonsteroidal anti-inflammatory drugs).

    In clinical studies, no pharmacokinetic interactions between sparfloxacin and theophylline have been established. However, it is possible to significantly reduce the threshold of seizure activity of the brain with the simultaneous use of quinolones with drugs that lower the threshold of seizure activity in the brain (theophylline, fenbufen [and other similar non-steroidal anti-inflammatory drugs]).

    Oral administration together with iron-containing preparations, sucralfate and antacid preparations containing magnesium, aluminum, calcium, zinc, and also iron salts, leads to a decrease in absorption of sparfloxacin (it should be prescribed 1-2 hours before, or no later than 4 hours after).

    Metoclopramide accelerates the absorption of sparfloxacin, which leads to a decrease in the time to reach its maximum concentration in the plasma.

    Drugs that extend the interval QT

    It should be taken into account the possible additive effect of lengthening the interval QT sparfloxacin and other drugs that affect the lengthening of the interval QT.

    Due to the joint use of sparfloxacin and drugs that affect the lengthening of the interval QT, the risk of developing ventricular arrhythmia increases, including polymorphic ventricular tachycardia (torsade de pointes). Contraindicated joint use of sparfloxacin with the following drugs that affect the lengthening of the interval QT:

    - antiarrhythmic drugs class IA (quinidine, hydroquinidine, disopyramide and dr);

    - antiarrhythmic drugs of class III (amiodarone, sotalol, dofetilide, ibutilide and etc.);

    - Neuroleptics (phenothiazine, pimozide, sertindole, haloperidol, sultopride, etc.);

    - Tricyclic antidepressants;

    - antimicrobials (moxifloxacin, erythromycin for intravenous administration, pentamidine, antimalarial drugs, especially halofantrine);

    - antihistamines (terfenadine, astemizole, misolastine);

    - others (cisapride, wincamine for intravenous administration, bepridil, difemanyl). When combined with other antimicrobials, synergy is usually observed (beta-lactams, aminoglycosides, clindamycin, metronidazole); sparfloxacin can be successfully used in combination with azlocillin and ceftazidime in infections caused by Pseudomonas spp., with mezlocillin, azlocillin and other beta-lactam antibiotics - with streptococcal infections; with penicillins resistant to the action of beta-lactamases, and vancomycin - with staphylococcal infections; with metronidazole and clindamycin - with anaerobic infections.

    With the simultaneous use of sparfloxacin with cyclosporine, there is an increase in serum creatinine, so these patients need control of this indicator 2 times a week.

    With glucocorticosteroids

    When used simultaneously with glucocorticosteroids, the risk of rupture of tendons increases, especially in elderly patients.

    With drugs that alkalinize urine (carbonic anhydrase inhibitors, citrates, sodium hydrogen carbonate)

    When administered with drugs that alkalinize urine (carbonic anhydrase inhibitors, citrates, sodium hydrogen carbonate), the risk of developing crystalluria and nephrotoxic effects increases.

    With oral hypoglycemic agents and insulin

    With the use of fluoroquinolones, the development of both hypoglycemia and hyperglycaemia has been reported, usually in patients with diabetes mellitus, who receive simultaneously oral hypoglycemic agents (for example, glibenclamide) or insulin. Therefore, it is recommended to carefully monitor blood glucose concentrations in patients with diabetes mellitus.

    With probenecid, cimetidine, furosemide or methotrexate

    When quinolones are used together with drugs that are excreted from the body through renal tubular secretion (such as probenecid, cimetidine, furosemide, methotrexate), there may be a relative delay in excretion and an increase in serum concentrations (especially if high doses are used). Sparfloxacin should be used with caution in patients taking drugs that reduce potassium (for example, loop and thiazide diuretics, laxatives, amphotericin B, corticosteroids), or drugs that cause clinically significant bradycardia.

    Special instructions:

    Renal insufficiency

    Due to sparfloxacin is mainly excreted by the kidneys, correction of the dose of sparfloxacin is necessary in patients with renal insufficiency (see sections "With caution", "Method of administration and dose").

    Crystalluria

    To avoid the development of crystalluria, do not exceed the recommended daily dose. It is necessary to consume sufficient fluid and maintain an acid reaction of urine.

    Prevention of photosensitization

    During treatment with sparfloxacin and within 5 days after its termination, exposure to bright sunlight and ultraviolet rays should be avoided due to the risk of photosensitization. Sparfloxacin is contraindicated in patients whose living or professional conditions do not allow them to comply with the required precautions.

    At the appearance of the first signs of phototoxicity, such as burning sensation of the skin, redness, swelling, blisters, rash, itching or dermatitis, treatment with sparfloxacin should be discontinued.

    Secondary infection

    As with the use of other antimicrobial agents with the use of sparfloxacin, especially prolonged, it is possible to develop a secondary infection associated with the growth of resistant to the preparation of microorganisms, to exclude and confirm which it is necessary to re-evaluate the patient's condition. If a secondary infection occurs during therapy, appropriate measures should be taken to treat it.

    Peripheral Neuropathy

    Patients receiving fluoroquinolones reported on the development of sensory and sensory-motor neuropathy, which may have a rapid onset. If patients develop neuropathy symptoms, treatment with sparfloxacin should be discontinued, thereby minimizing the possible risk of developing irreversible conditions (see "With caution").

    Patients with glucose-6-phosphate dehydrogenase deficiency

    Patients with diagnosed glucose-6-phosphate dehydrogenase deficiency may be predisposed to hemolytic reactions when treated with quinolones (see "Contraindications").

    Pseudomembranous colitis, caused by Clostridium difficile

    The appearance of diarrhea, especially in severe form, persistent and / or with an admixture of blood, during or after treatment with sparfloxacin may be a manifestation of pseudomembranous colitis. If suspected development of pseudomembranous colitis, treatment with sparfloxacin should be stopped immediately, and appropriate specific antibiotic therapy should be immediately prescribed (Vancomycin inside, teicoplanin inside or metronidazole inside). In the emergence of this clinical situation, preparations that suppress the intestinal peristalsis are contraindicated.

    Patients who are predisposed to develop seizures

    Like other quinolones, sparfloxacin should be used with caution in patients predisposed to develop seizures (patients with a history of CNS lesions, in patients who simultaneously receive drugs that reduce the threshold of seizure activity of the brain (theophylline, fenbufen [and other similar non-steroidal anti-inflammatory drugs]) (see "With caution"). With the development of seizures, treatment with sparfloxacin should be discontinued.

    Tendonitis

    Tendinitis, rarely caused by the use of quinolones, can sometimes lead to rupture of tendons, including Achilles tendon, especially in elderly patients and patients taking glucocorticosteroids simultaneously. This undesirable effect can develop within 48 hours after the start of treatment and be bilateral. In case of signs of tendonitis (inflammation of the tendon), it is recommended to immediately stop treatment. An appropriate treatment (for example, immobilization) of a damaged tendon may be required.

    Interval lengthening QT

    When using sparfloxacin, some patients may experience lengthening interval QT. Sparfloxacin should be used with caution in women and elderly patients. Because women have a longer interval than men QT, they may be more sensitive to drugs that extend the interval QT. Elderly patients are also more prone to the effects of drugs that affect the interval QT.

    Interval lengthening QT is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia.

    Degree of lengthening interval QT may increase with increasing drug concentration, therefore, do not exceed the recommended dose.

    When using sparfloxacin, the risk of developing ventricular arrhythmias in patients with predisposing arrhythmias may increase.

    Concerning sparfloxacin contraindicated in:

    - changes in the electrophysiological parameters of the heart, expressed in the lengthening of the interval QT: Congenital or acquired documented lengthening interval QT, electrolyte disturbances, especially uncorrected hypokalemia, clinically significant bradycardia; clinically significant heart failure with a reduced fraction of the left ventricular ejection; presence in the anamnesis of rhythm disturbances, accompanied by clinical symptoms:

    - use with other drugs that extend the interval QT (see section "Interaction with other drugs").

    Sparfloxacin should be used with caution:

    - in patients with potentially proarrhythmic conditions,such as acute myocardial ischemia and cardiac arrest;

    - in patients taking drugs, reducing the content of potassium.

    Pseudo-paralytic myasthenia gravis (myasthenia gravis)

    Fluoroquinolones are characterized by a neuromuscular blocking activity and may increase muscle weakness in patients with pseudo-paralytic myasthenia gravis. In the post-marketing period, serious adverse reactions were observed, including pulmonary insufficiency requiring artificial ventilation and fatal outcome, which were associated with the use of fluoroquinolones in patients with pseudo-paralytic myasthenia gravis. The use of sparfloxacin in a patient with an established diagnosis of pseudo-paralytic myasthenia is not recommended.

    Severe skin reactions

    When taking sparfloxacin, the development of severe bullous reactions, as Stevens-Johnson syndrome, toxic epidermal necrolysis. Patients should be informed that with the development of skin reactions and / or lesions of the mucous membranes, it is necessary to consult a doctor immediately before proceeding with sparfloxacin.

    Hypersensitivity reactions and allergic reactions

    With the use of fluoroquinolones, the development of hypersensitivity reactions and allergic reactions (anaphylactic shock and anaphylactoid reactions that can progress to a life-threatening state) has been reported. In these cases, the use of sparfloxacin should be discontinued and appropriate treatment initiated.

    Psychotic reactions

    Psychotic reactions, including suicidal thoughts / attempts, were noted in patients taking fluoroquinolones. In the case of the development of such reactions sparfloxacin should be canceled and appropriate treatment prescribed. Sparfloxacin should be administered with caution to patients with psychotic disorders (including history) (see section "With caution").

    Dysfunction of the liver

    Sparfloxacin should be used with caution in patients with impaired hepatic function, as liver damage may occur (see "With caution"). With the use of fluoroquinolones, cases of fulminant hepatitis have been reported, leading to the development of hepatic insufficiency (including fatal cases).Patients should be advised to stop treatment and consult a doctor if symptoms and signs of liver disease such as anorexia, jaundice, darkening of the urine, pruritus, abdominal pain are observed.

    Disglycemia (hypo- and hyperglycemia)

    With the use of fluoroquinolones, the development of both hypoglycemia and hyperglycemia has been reported. In patients with diabetes mellitus, receiving simultaneously oral hypoglycemic agents (for example, glibenclamide) or insulin, was reported on the development of hypoglycemic coma. It is recommended that blood glucose concentrations be carefully monitored in patients with diabetes mellitus.

    Risk of development of resistance

    The prevalence of acquired resistance may vary geographically and over time for individual species. Therefore, local information on resistance is required. It is necessary to carry out microbiological diagnostics with isolation of the pathogen and determination of its sensitivity, especially in severe infections or lack of response to treatment.

    Infections caused by Escherichia coli

    Resistance to fluoroquinolones Escherichia coli - the most common pathogen of urinary tract infections - varies indifferent geographic areas. Doctors are advised to take into account local resistance Escherichia coli to fluoroquinolones.

    Infections caused by Neisseria gonorrhoeae

    In connection with the increase in resistance Neisseria gonorrhoeae, sparfloxacin Do not use as an empirical treatment for suspected gonococcal urinary tract infection. Test for sensitivity of the pathogen to sparfloxacin should be performed in order to provide targeted therapy.

    Methicillin-resistant Staphylococcus aureus

    There is a high probability that methicillin-resistant Staphylococcus aureus will be resistant to fluoroquinolones. therefore sparfloxacin is not recommended for the treatment of established or suspected infections caused by methicillin-resistant Staphylococcus aureus, if laboratory tests did not confirm the sensitivity of this microorganism to sparfloxacin.

    Infections of bones and joints

    When infections of bones and joints should consider the need for combined use of sparfloxacin with other antibacterial drugs.

    Impact on laboratory performance and diagnostic tests

    Sparfloxacin can inhibit growth Mycobacterium tuberculosis, leading to false-negative results in the bacteriological diagnosis of tuberculosis.

    When determining opiates and porphyrins in urine during treatment with sparfloxacin, a false positive result is possible. It may be necessary to confirm positive results using more specific methods.

    Other

    During the period of treatment is not recommended to use ethanol.

    Effect on the ability to drive transp. cf. and fur:

    During treatment with sparfloxacin, one should refrain from engaging in potentially dangerous activities that require increased attention and speed of psychomotor and motor reactions.

    Form release / dosage:

    Tablets, film-coated, 200 mg.

    Packaging:

    For 6 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    On 1 contour acheikova packing together with the instruction on application place in a pack from a cardboard.

    Storage conditions:

    In a place protected from moisture and light at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-004411
    Date of registration:15.08.2017
    Expiration Date:15.08.2022
    The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp06.09.2017
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